Implantable neuromodulation systems have proven therapeutic in a wide variety of diseases and disorders. Pacemakers and Implantable Cardiac Defibrillators (ICDs) have proven highly effective in the treatment of a number of cardiac conditions (e.g., arrhythmias). Spinal Cord Stimulation (SCS) systems have long been accepted as a therapeutic modality for the treatment of chronic pain syndromes, and the application of spinal modulation has begun to expand to additional applications, such as angina pectoris and incontinence. Deep Brain Stimulation (DBS) has also been applied therapeutically for well over a decade for the treatment of refractory Parkinson's Disease, and DBS has also recently been applied in additional areas, such as essential tremor and epilepsy. Further, in recent investigations, Peripheral Nerve Stimulation (PNS) systems have demonstrated efficacy in the treatment of chronic pain syndromes and incontinence, and a number of additional applications are currently under investigation. Furthermore, Functional Electrical Stimulation (FES) systems such as the Freehand system by NeuroControl (Cleveland, Ohio) have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients.
Each of these implantable neuromodulation systems typically includes one or more electrode carrying modulation leads, which are implanted at the desired stimulation site, and a neuromodulation device implanted remotely from the stimulation site, but coupled either directly to the modulation lead(s) or indirectly to the modulation lead(s) via a lead extension. Thus, electrical pulses can be delivered from the neuromodulation device to the electrode(s) to modulate a volume of tissue in accordance with a set of modulation parameters and provide the desired efficacious therapy to the patient. For example, electrical energy conveyed between at least one cathodic electrode and at least one anodic electrode creates an electrical field, which when strong enough, depolarizes (or “stimulates”) the neurons beyond a threshold level, thereby inducing the firing of action potentials (APs) that propagate along the neural fibers. A typical modulation parameter set may include the electrodes that are sourcing (anodes) or returning (cathodes) the modulating current at any given time, as well as the amplitude, duration, and rate of the electrical modulation pulses.
The neuromodulation system may further comprise a handheld patient programmer to remotely instruct the neuromodulation device to generate electrical modulation pulses in accordance with selected modulation parameters. The handheld programmer in the form of a remote control (RC) may, itself, be programmed by a clinician, for example, by using a clinician's programmer (CP), which typically includes a general purpose computer, such as a laptop, with a programming software package installed thereon.
The RC and/or the CP communicate telemetrically with the neuromodulation device. Current neuromodulation systems use a single telemetry system where the range is typically limited to a few feet and the data transfer rate is relatively low. The limited range of the telemetry system allows the neuromodulation device to be programmed, while avoiding interference from spurious/malicious communications with the implanted device. The relatively low data transfer rate is sufficient for transmitting a small amount of programming data to and from the implanted neuromodulation device.
However, there is a need to store large amounts of data in the implanted device to enable seamless programming of the device when programmed using different external systems. In one example, for DBS, the pre-op MRI and the post-op CT are used to identify brain structures and the lead position inside the brain. These images are then manipulated in a process called registration to identify patient-specific brain structures and to transform a generic brain atlas into a patient-specific brain atlas. The MRI and CT data are typically large datasets that are retrieved and stored from radiography CDs onto external programming systems. If the patient is seen by a different system/clinic, this information is not readily available. It is practically impossible to transfer this large amount of data to the implanted neuromodulation device with the current low speed, short range telemetry systems.
There, thus, remains a need for a high speed telemetry system that will enable the quick transfer of large amounts of data to and from the neuromodulation device for use by any external device.